Healthcare

Medical Law practice presupposes a deep engagement with current and upcoming legal issues and a commitment to work with institutions and patients. Our experienced and dedicated team manages issues related to ethics, digital health, consent to treatment in clinical trials and personalized treatment while patients are empowered to become more involved in decisions about their own treatment and can raise malpractice issues. We also offer comprehensive training programs for clinicians and hospital administration staff including obtaining consent, avoiding breaches of confidentiality and properly recording consent in real-life scenarios. Whatever your institutional ambitions or private concerns, we will mobilize our expertise and experience to form health law solutions which deliver your objectives efficiently and effectively.

Pharma & Biotech

Whether your business belongs to Pharma or Biotech, it needs corporate or commercial advice and guidance, faces compliance and corporate governance issues, or requires expert advice on pharma compliance, intellectual property, data protection, parallel trade, clinical negligence and public procurement, our team of health law experts has your back. We offer legal services on the approval, marketing and promotion of pharmaceutical products, we advise veterinary pharma companies, procure license and R&D agreements and advise you on product liability, your interactions with HCPs and HCOs, third party agreements, claw-back and rebate issues. Moreover, we have considerable experience in clinical drug trials and research, as well as in the production and marketing authorization of cannabis medicinal products. Therefore, our expertise extends to the full range of legal actions required for the notification and distribution of over-the-counter (OTC) products, cosmetics and food supplements. Our deep engagement with the corporate, commercial side of the pharmaceutical law also ensures attention to all the financial aspects of drug trials, as well as risk management of clinical pathways and protocols.

Medical Devices & In Vitro Diagnostics

In a highly competitive field that constantly evolves, our team is always up-to-date on the latest legal developments. While the new MDR and IVDR set new challenges for medical device companies, our lawyers help you navigate the new standards imposed by the EU legal framework: CE marking, product classification, adverse incident reporting, incident handling and complaints as well as parallel imports. In addition, we assist you with market access and reimbursement, product liability, promotion and advertising, public tenders, supply and distribution agreements, interactions with HCPs and HCOs. Our team provides practical advice on the full product lifecycle, from R&D and classification to marketing claims and inspections. We have significant expertise on the technical requirements of digital health solutions, e-health, m-health and other software-driven innovations.

IC Technology

New digital technologies create unique legal challenges for businesses involved in information, technology and e-commerce. Harmonizing their procedures in order to ensure full compliance with applicable local and European laws and regulations regarding e-commerce, IPR and information technology law requires a bird’s eye view on the evolving regulatory landscape. We focus on our clients’ particular needs and interests; we undertake a full range of legal actions in order to prepare their businesses to navigate the requirements of the digital space, such as drafting Terms of Use, Confidentiality Clauses and Privacy Policies tailored to their app needs, features and data use and provide our legal opinion on intellectual property rights and trademark issues alongside day-to-day support for every other activity related to digital actions.

Food

We assist clients in all aspects of food and beverage product development, safety, labelling, and promotion. We have substantial experience in the regulatory requirements for specific types of foods, medical, organic, animal foods and novel foods. Novel food is greatly related to health and well-being and has been included in the current or upcoming portfolio of many healthcare and food businesses. The existing EU legal framework sets specific conditions regarding the marketing of novel foods and for this reason, specialized legal advice in this newcomer field provides solid competitive advantages. Our experienced team offers legal advice in a wide range of issues related to the marketing and promotion of novel foods, health claims, labelling, notification to regulatory authorities, commercial agreements as well as litigation.

TOP